NCT00704678已完成2 期
A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Responder rates achieving target serum phosphate levels.
研究概览
简要总结
This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
1g bid
干预措施: SBR759 (Drug)
2
Active Comparator
0.8 g tid
干预措施: Sevelamer HCl (Drug)
3
Experimental
1.5 g tid
干预措施: Sevelamer HCl (Drug)
4
Active Comparator
1.6 g tid
干预措施: Sevelamer HCl (Drug)
结局指标
主要结局
Responder rates achieving target serum phosphate levels.
时间窗: Week 12
次要结局
- Responder rates in target patients with serum calcium-phosphate levels.(Week 12)
研究者
研究点 (1)
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不适用
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